Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083567
Company: HIKMA INTL PHARMS
Company: HIKMA INTL PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | CAPSULE;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/25/1973 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/01/1990 | SUPPL-19 | Bioequivalence |
Label is not available on this site. |
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05/01/1989 | SUPPL-17 | Labeling |
Label is not available on this site. |
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08/22/1986 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |